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Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719691
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : January 19, 2022
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Breast Cancer
Solid Tumors
Interventions Drug: Alisertib
Drug: MLN0128
Enrollment 47
Recruitment Details  
Pre-assignment Details This study had a dose escalation cohort followed by expansion cohorts. We had 65 patients consented and 18 patients were not eligible due to not meeting inclusion exclusion criteria. 1 subject withdrew by choice, 1 withdrew per Physician discretion..
Arm/Group Title Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 4: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose-Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cancer Cohort:
Hide Arm/Group Description

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21. This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21. This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
Period Title: Overall Study
Started 3 4 7 2 10 10 11
Completed 3 4 6 2 10 9 11
Not Completed 0 0 1 0 0 1 0
Reason Not Completed
Physician Decision             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             0
Arm/Group Title Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose-Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cancer Cohort Total
Hide Arm/Group Description

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

Total of all reporting groups
Overall Number of Baseline Participants 3 4 6 2 10 9 11 45
Hide Baseline Analysis Population Description
1 subject in the expansion cohort withdrew by choice, 1 subject in the dose-escalation (Level 3) withdrew by Physician decision. Analysis was completed on 45 subjects.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 6 participants 2 participants 10 participants 9 participants 11 participants 45 participants
<=18 years 0 0 0 0 0 0 0 0
Between 18 and 65 years 2 2 2 1 6 4 9 26
>=65 years 1 2 4 1 4 5 2 19
[1]
Measure Analysis Population Description: 2 subjects were not analyzed as they were withdrawn from the study.
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 6 participants 2 participants 10 participants 9 participants 11 participants 45 participants
63.7
(60 to 68)
64.8
(59 to 69)
64.5
(48 to 76)
65.5
(57 to 74)
61.7
(51 to 72)
61.9
(40 to 75)
56.9
(39 to 74)
61.4
(39 to 76)
[1]
Measure Analysis Population Description: 2 subjects were not analyzed as they were withdrawn from the study.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 6 participants 2 participants 10 participants 9 participants 11 participants 45 participants
Female
2
  66.7%
4
 100.0%
5
  83.3%
2
 100.0%
8
  80.0%
6
  66.7%
2
  18.2%
29
  64.4%
Male
1
  33.3%
0
   0.0%
1
  16.7%
0
   0.0%
2
  20.0%
3
  33.3%
9
  81.8%
16
  35.6%
[1]
Measure Analysis Population Description: 2 subjects were not analyzed as they were withdrawn from the study.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 6 participants 2 participants 10 participants 9 participants 11 participants 45 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
  10.0%
1
  11.1%
3
  27.3%
6
  13.3%
Not Hispanic or Latino
3
 100.0%
4
 100.0%
4
  66.7%
2
 100.0%
9
  90.0%
8
  88.9%
8
  72.7%
38
  84.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
[1]
Measure Analysis Population Description: 2 subjects were not analyzed as they were withdrawn from the study.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 6 participants 2 participants 10 participants 9 participants 11 participants 45 participants
3 4 6 2 10 9 11 45
[1]
Measure Analysis Population Description: 2 subjects were not analyzed as they were withdrawn from the study.
1.Primary Outcome
Title The Maximum Tolerated Dose (MTD) in the Combination of MLN0128 and Alisertib in Patients With Advanced Solid Tumors Measured by Treatment Adverse Events as Assessed by the CTCAE v4.03
Hide Description The maximum tolerated dose (MTD) will be defined as the highest dose level evaluated in which 0 or 1 patient out of 6 patients experiences dose limiting toxicity (DLT) in the combination of MLN0128 and Alisertib. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-Escalation of Alisertib and MLN0128
Hide Arm/Group Description:

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: mg
alisertib 30
TAK228 2
2.Secondary Outcome
Title The Safety Profile and Tolerability of the Combination of MLN0128 and Alisertib in Adult Patients With Advanced Solid Tumors.
Hide Description Adverse events will be tabulated by type and grade according to the NCI CTCAE v.4.03. Please see adverse events section.
Time Frame At least 30 days after the last dose of MLN0128 or alisertib
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with at least one adverse event.
Arm/Group Title Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 4: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cancer Cohort
Hide Arm/Group Description:

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21.
This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
Overall Number of Participants Analyzed 3 4 7 2 10 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
4
 100.0%
7
 100.0%
2
 100.0%
10
 100.0%
10
 100.0%
11
 100.0%
Time Frame 3 years, 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 4: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose-Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cohort
Hide Arm/Group Description

This group will receive a Dose-Escalation: Combination of MLN0128 and Alisertib using a standard 3 + 3 design. The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 1 mg given by mouth (PO) once daily with continuous dosing.

Alisertib: Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.

MLN0128: Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.

The starting dose of Alisertib is 30 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing. The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 2 mg given by mouth (PO) once daily with continuous dosing. The starting dose of Alisertib is 40 mg given PO twice daily (BID) Days 1-7 repeat every 21 days. The starting dose for MLN0128 is 3 mg given by mouth (PO) once daily with continuous dosing. This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, single agent Alisertib will be administered at the MTD on days 1-7 and MLN0128 will be administered on days 8-21. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21. This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. In cycle 1, MLN0128 will be administered at the MTD days 1-28 and Alisertib will be administered at the MTD on days 8-15. In cycle 2 and beyond, dosing with both agents will begin on day 1, with Alisertib administered days 1-7 and MLN0128 administered days 1-21. This group will receive a Dose-Expansion of Alisertib and Dose-Expansion of MLN0128. On each cycle, Alisertib will be administered on days 1-7, while MLN0128 will be administered continuously on days 1-21.
All-Cause Mortality
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 4: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose-Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/4 (0.00%)      0/7 (0.00%)      0/2 (0.00%)      7/10 (70.00%)      9/10 (90.00%)      8/11 (72.73%)    
Hide Serious Adverse Events
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 4: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose-Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/4 (0.00%)      2/7 (28.57%)      2/2 (100.00%)      3/10 (30.00%)      4/10 (40.00%)      6/11 (54.55%)    
Blood and lymphatic system disorders               
thromboembolic event   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Sepsis   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 1/11 (9.09%)  1
Febrile Neutropenia   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Cardiac disorders               
Hypotension   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Congenital, familial and genetic disorders               
vomitting   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders               
Small bowel obstruction   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
dehydration   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0
gi bleed   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Nausea   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 1/2 (50.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
ileus   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
pancreatitis   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
General disorders               
pain   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 2/11 (18.18%)  3
death progression of disease   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0
Infections and infestations               
infection   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders               
hip fracture   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders               
encephalopathy   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0
Renal and urinary disorders               
Acute Kidney Injury   1/3 (33.33%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
dyspnea   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/11 (0.00%)  0
hypoxia   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1: Alisertib 30 mg/MLN0128 1 mg Dose Level 2: Alisertib 30 mg/MLN0128 2 mg Dose Level 3: Alisertib 40 mg/MLN0128 2 mg Dose Level 4: Alisertib 40 mg/MLN0128 3 mg Dose-Expansion of Alisertib and MLN0128: Group 1 Dose-Expansion of Alisertib and MLN0128: Group 2 Pancreatic Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      4/4 (100.00%)      7/7 (100.00%)      2/2 (100.00%)      10/10 (100.00%)      10/10 (100.00%)      11/11 (100.00%)    
Blood and lymphatic system disorders               
Anemia   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  3 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1
Alkaline Phosphatase   0/3 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2
Neutrophil Count Decreased   0/3 (0.00%)  0 2/4 (50.00%)  5 4/7 (57.14%)  7 1/2 (50.00%)  1 1/10 (10.00%)  2 1/10 (10.00%)  1 3/11 (27.27%)  8
Platelet Count Decreased   0/3 (0.00%)  0 0/4 (0.00%)  0 2/7 (28.57%)  3 0/2 (0.00%)  0 1/10 (10.00%)  3 1/10 (10.00%)  1 1/11 (9.09%)  1
Pruritis   1/3 (33.33%)  1 1/4 (25.00%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0 2/11 (18.18%)  2
Alanine Aminotransferase Increased   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2
Ascites   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2
AST Increase   0/3 (0.00%)  0 1/4 (25.00%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 2/10 (20.00%)  2 1/10 (10.00%)  1 1/11 (9.09%)  1
Endocrine disorders               
Hyperglycemia   1/3 (33.33%)  1 1/4 (25.00%)  1 0/7 (0.00%)  0 1/2 (50.00%)  1 3/10 (30.00%)  4 2/10 (20.00%)  3 3/11 (27.27%)  3
Gastrointestinal disorders               
Constipation   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 1/2 (50.00%)  1 2/10 (20.00%)  2 1/10 (10.00%)  1 1/11 (9.09%)  2
Diarrhea   0/3 (0.00%)  0 2/4 (50.00%)  2 2/7 (28.57%)  2 0/2 (0.00%)  0 4/10 (40.00%)  9 2/10 (20.00%)  2 7/11 (63.64%)  8
Nausea   1/3 (33.33%)  1 0/4 (0.00%)  0 6/7 (85.71%)  7 1/2 (50.00%)  1 2/10 (20.00%)  2 3/10 (30.00%)  3 6/11 (54.55%)  8
Vomiting   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0
General disorders               
Anorexia   0/3 (0.00%)  0 0/4 (0.00%)  0 4/7 (57.14%)  4 0/2 (0.00%)  0 2/10 (20.00%)  2 2/10 (20.00%)  2 4/11 (36.36%)  4
Fatigue   2/3 (66.67%)  2 2/4 (50.00%)  3 3/7 (42.86%)  3 2/2 (100.00%)  6 4/10 (40.00%)  4 7/10 (70.00%)  7 7/11 (63.64%)  9
Headache   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0
Abdominal Pain   1/3 (33.33%)  1 0/4 (0.00%)  0 2/7 (28.57%)  2 0/2 (0.00%)  0 3/10 (30.00%)  4 2/10 (20.00%)  2 6/11 (54.55%)  7
Back Pain   0/3 (0.00%)  0 0/4 (0.00%)  0 2/7 (28.57%)  2 0/2 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 1/11 (9.09%)  1
Infections and infestations               
Lung Infection   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Renal and urinary disorders               
Acute Kidney Injury   0/3 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2
Respiratory, thoracic and mediastinal disorders               
Dyspnea   0/3 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders               
Alopecia   1/3 (33.33%)  1 1/4 (25.00%)  1 1/7 (14.29%)  1 0/2 (0.00%)  0 3/10 (30.00%)  3 0/10 (0.00%)  0 0/11 (0.00%)  0
Mucositis   0/3 (0.00%)  0 1/4 (25.00%)  2 1/7 (14.29%)  1 0/2 (0.00%)  0 5/10 (50.00%)  12 1/10 (10.00%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Diamond, MD
Organization: University of Colorado
Phone: 303-724-5499
EMail: jennifer.diamond@cuanschutz.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02719691    
Other Study ID Numbers: 15-1135.cc
First Submitted: March 21, 2016
First Posted: March 25, 2016
Results First Submitted: October 27, 2021
Results First Posted: January 19, 2022
Last Update Posted: July 25, 2022